Allogene Therapeutics Reports Second Quarter 2021 Financial Results
August 04 2021 - 4:02PM
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage
biotechnology company pioneering the development of allogeneic CAR
T (AlloCAR T™) therapies for cancer, today provided a corporate
update and reported second quarter 2021 financial results for the
quarter ended June 30, 2021.
“We have made exceptional progress across our broad pipeline of
AlloCAR T candidates, bringing our goal of revolutionizing cell
therapy for patients with blood cancers and solid tumors closer to
reality,” said David Chang, M.D., Ph.D., President, Chief Executive
Officer and Co-Founder of Allogene. “Our foundational and ongoing
work has the potential to drive us toward an industry first - our
planned pivotal trial for ALLO-501A in relapsed/refractory
non-Hodgkin lymphoma which we expect to initiate at the end of this
year. This month, we are also marking an exciting milestone with
the planned inauguration of our state-of-the-art manufacturing
facility, Cell Forge 1. This facility is intended to allow us to
control manufacturing of ALLO-501A and future therapies and prepare
us for potential commercialization.”
Pipeline Highlights
Anti-CD19 Program: ALPHA and ALPHA2 Trials
- Updated data from the ongoing Phase 1 ALPHA (ALLO-501) and
ALPHA2 (ALLO-501A) trials in relapsed/refractory non-Hodgkin
lymphoma (NHL) presented at the Company’s CD19 Forum in May and
Annual Meeting of the American Society of Clinical Oncology (ASCO)
in June.
- Data from the ALPHA trial supports the ability of a single
administration of ALLO-501 to generate deep and durable responses
at a rate that is similar to approved autologous CAR T therapies.
In the trial, 98% of patients received ALLO-501 with an average
time from enrollment to the start of therapy of five days.
- Durable complete responses (CR) were observed with the longest
ongoing CR at 15 months in both large B cell lymphoma (LBCL) and
follicular lymphoma.
- Overall response rate (ORR) of 75% and CR rate of 50% across
histologies in CAR T naïve patients, and on par with data from
pivotal trials of autologous CAR T therapies.
- Six-month CR rate of 36% in CAR T naïve patients with
LBCL.
- Interim Phase 1 ALPHA2 data demonstrated a comparable efficacy
and safety profile for ALLO-501A relative to ALLO-501.
- Consolidation dosing was well tolerated and showed early
promise with four patients converting from partial response (PR) to
CR following second dose of ALLO-501 or ALLO-501A.
- 75% ORR and 63% CR among patients (n=8) treated in the
consolidation cohorts across ALPHA studies.
- ALLO-501 and ALLO-501A demonstrated a manageable safety profile
with no dose limiting toxicities or graft-vs-host disease, limited
immune effector cell-associated neurotoxicity syndrome (ICANS) and
cytokine release syndrome (CRS) observed.
- Next readout from this program is expected in late 2021.
- The Company plans to collect additional data from the
consolidation arms of the ALPHA and ALPHA2 studies, finalize a dose
and schedule of ALLO-501A and lymphodepletion for a pivotal Phase 2
trial, and discuss the Phase 2 trial design with regulatory
authorities.
- Pending regulatory feedback, the Company plans to move to the
Phase 2 Pivotal ALPHA2 trial at the end of 2021.
Anti-BCMA AlloCAR T ProgramThe Company
continues to advance its portfolio of allogeneic therapies
targeting the B cell maturation antigen (BCMA) for patients with
multiple myeloma (MM).
- ALLO-715 UNIVERSAL Trial
- The UNIVERSAL trial, investigating ALLO-715 as a monotherapy
and in combination with nirogacestat, SpringWorks Therapeutics’
investigational gamma secretase inhibitor, continues to enroll
patients with relapsed/refractory MM.
- Updated data from the monotherapy arm of the study are
anticipated in Q4 2021.
- In April, ALLO-715 was granted Regenerative Medicine Advanced
Therapy (RMAT) designation by the U.S. Food and Drug Administration
(FDA).
- ALLO-605 TurboCAR™ IGNITE Trial
- The Phase 1 dose escalation portion of the IGNITE trial
evaluating ALLO-605, the first anti-BCMA TurboCAR T cell therapy,
began dosing patients.
- In June, the FDA granted ALLO-605 Fast Track designation based
on the potential of ALLO-605 to address the unmet need for patients
who have failed other standard MM therapies.
Solid Tumor AlloCAR T Program
- ALLO-316 (anti-CD70) TRAVERSE TrialThe Phase 1
TRAVERSE trial of ALLO-316, Allogene’s first CAR T candidate for
solid tumors, in patients with advanced or metastatic clear cell
renal cell carcinoma (ccRCC) continues to progress with initial
data anticipated in 2022. The trial is examining safety,
tolerability, anti-tumor efficacy, pharmacokinetics and
pharmacodynamics of ALLO-316.
Corporate Highlights
- Manufacturing Updates
- The Company plans to unveil its state-of-the-art cGMP cell
manufacturing facility, Cell Forge 1, in Newark, California in
preparation for a pivotal trial of ALLO-501A and future
commercialization. Company is on track to begin cGMP production in
this facility in the second half of 2021.
- Allogene Overland Biopharm
- Allogene Overland Biopharm, a joint venture created with
Overland Pharmaceuticals, appointed Shuyuan Yao, Ph.D., as
Chief Executive Officer. Dr. Yao brings 15 years of
scientific and management experience in advanced cell and gene
therapy development, manufacturing and commercialization, and will
lead Allogene Overland in its mission to bring certain AlloCAR T
therapies to patients in China and other Asian Pacific
markets.
Second Quarter Financial Results
- Research and development expenses were $52.3
million for the second quarter of 2021, which
includes $10.5 million of non-cash stock-based
compensation expense.
- General and administrative expenses were $18.8
million for the second quarter of 2021, which
includes $10.6 million of non-cash stock-based
compensation expense.
- Net loss for the second quarter of 2021 was $70.9 million,
or $0.53 per share, including non-cash stock-based
compensation expense of $21.1 million.
- The Company had $913.2 million in cash, cash equivalents, and
investments as of June 30, 2021.
Allogene continues to expect full year GAAP Operating Expenses
to be between $300 million and $330
million including estimated non-cash stock-based compensation
expense of $80 million to $90 million and
excluding any impact from potential new business development
activities.
Conference Call and Webcast DetailsAllogene
will host a live conference call and webcast today at 2:00 p.m.
Pacific Time / 5:00 p.m. Eastern Time to discuss financial results
and provide a business update. To access the live conference call
by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409)
216-0618 (International). The conference ID number for the live
call is 8080137. The webcast will be made available on the
Company's website at www.allogene.com under the Investors tab in
the News and Events section. Following the live audio webcast, a
replay will be available on the Company's website for approximately
30 days.
About Allogene TherapeuticsAllogene
Therapeutics, with headquarters in South San Francisco, is a
clinical-stage biotechnology company pioneering the development of
allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies
for cancer. Led by a management team with significant experience in
cell therapy, Allogene is developing a pipeline of “off-the-shelf”
CAR T cell therapy candidates with the goal of delivering readily
available cell therapy on-demand, more reliably, and at greater
scale to more patients. For more information, please visit
www.allogene.com and follow @AllogeneTx on Twitter and
LinkedIn.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. The press release
may, in some cases, use terms such as "predicts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should" or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the timing and ability to progress
the ALPHA, ALPHA2, UNIVERSAL, IGNITE and TRAVERSE trials, including
progressing to the Phase 2 portion of the ALPHA2 trial, and present
any data from the trials; clinical outcomes, which may materially
change as patient enrollment continues and more patient data become
available; the ability to manufacture AlloCAR T™ therapies,
including for use in clinical trials and at the Company’s
manufacturing facility; the potential benefits of AlloCAR T™
therapy; and the 2021 financial guidance. Various factors may cause
differences between Allogene’s expectations and actual results as
discussed in greater detail in Allogene’s filings with the
Securities and Exchange Commission (SEC), including without
limitation in its Form 10-Q for the quarter ended June 30, 2021.
Any forward-looking statements that are made in this press release
speak only as of the date of this press release. Allogene assumes
no obligation to update the forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release.
Comparative statements regarding autologous CAR T data are based
on review of Kymriah United States product insert (USPI), Schuster
S et al NEJM 2019; Yescarta USPI, Locke, AACR 2017; and Breyanzi
USPI. Caution should be exercised when interpreting results from
separate trials involving separate product candidates. There are
differences in the clinical trial design, patient populations,
published data, and the product candidates themselves, and the
results from the clinical trials of autologous products may have no
interpretative value on our existing or future results.
AlloCAR T™ and TurboCAR™ are trademarks of Allogene
Therapeutics, Inc.
Allogene’s CD19 AlloCAR T program utilizes Cellectis
technologies. ALLO-501 and ALLO-501A are being jointly developed
under a collaboration agreement between Servier1 and Allogene based
on an exclusive license granted by Cellectis to Servier. Servier
grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in
the U.S. while Servier retains exclusive rights for all other
countries. The anti-BCMA and anti-CD70 AlloCAR T programs, which
utilize the Cellectis TALEN® technology, are licensed exclusively
from Cellectis by Allogene and Allogene holds global development
and commercial rights to these AlloCAR T programs.
_____________________________________
1 Servier is an independent international pharmaceutical company
governed by a non-profit foundation, with its headquarters in
France (Suresnes).
ALLOGENE THERAPEUTICS, INC.SELECTED
FINANCIAL DATA(unaudited; in thousands, except share and
per share data)
STATEMENTS OF OPERATIONS
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue - related party |
$ |
44 |
|
|
|
$ |
— |
|
|
|
$ |
38,389 |
|
|
|
$ |
— |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
52,290 |
|
|
|
$ |
47,296 |
|
|
|
$ |
107,473 |
|
|
|
$ |
89,337 |
|
|
General and administrative |
18,783 |
|
|
|
15,862 |
|
|
|
35,146 |
|
|
|
31,502 |
|
|
Total operating expenses |
71,073 |
|
|
|
63,158 |
|
|
|
142,619 |
|
|
|
120,839 |
|
|
Loss from operations |
(71,029 |
) |
|
|
(63,158 |
) |
|
|
(104,230 |
) |
|
|
(120,839 |
) |
|
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest and other income, net |
624 |
|
|
|
2,340 |
|
|
|
1,135 |
|
|
|
5,600 |
|
|
Other expenses |
(531 |
) |
|
|
(156 |
) |
|
|
(856 |
) |
|
|
(215 |
) |
|
Total
other income (expense), net |
93 |
|
|
|
2,184 |
|
|
|
279 |
|
|
|
5,385 |
|
|
Net loss |
(70,936 |
) |
|
|
(60,974 |
) |
|
|
(103,951 |
) |
|
|
(115,454 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.53 |
) |
|
|
$ |
(0.53 |
) |
|
|
$ |
(0.78 |
) |
|
|
$ |
(1.03 |
) |
|
Weighted-average number of
shares used in computing net loss per share, basic and diluted |
134,826,805 |
|
|
|
115,377,210 |
|
|
|
133,503,262 |
|
|
|
112,163,123 |
|
|
SELECTED BALANCE SHEET DATA
|
As of June 30, 2021 |
|
As of December 31, 2020 |
Cash, cash equivalents and investments |
$ |
913,230 |
|
|
$ |
1,032,118 |
|
Total assets |
1,126,724 |
|
|
1,227,829 |
|
Total liabilities |
102,912 |
|
|
148,212 |
|
Total stockholders’
equity |
1,023,812 |
|
|
1,079,617 |
|
Allogene Media/Investor Contact:Christine
CassianoChief Communications Officer(714)
552-0326Christine.Cassiano@allogene.com
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